FDA (Devices) recall action 66893
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Modification of the bacterial overflow guard (filter) and related changes to product labeling.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Smith & Nephew is recalling Renasys EZ PLUS canisters to modify the bacterial overflow guard and update product labeling.
Smith & Nephew is recalling Renasys EZ canisters to modify the bacterial overflow guard and update product labeling.